Garite 1981.

Methods	RCT Duration of study: May 1977‐July 1980
Participants	Setting: Obstetric services at the University of California Irvine Medical Center and Women's Hospital Memorial Medical Center of Long Beach, Orange County, California, USA Participants: 160 women; 80 women in early delivery group and 80 women in expectant management group Inclusion criteria Women with preterm premature rupture of the membranes 28‐34 weeks' gestation Exclusion criteria Fetal distress Chorioamnionitis Mature L/S ratio Advanced labour Prior to randomisation all women Monitored with an external fetal heart rate monitor for a minimum of 30 min Ultrasound examination performed where BPD determined. Amniocentesis performed for L/S ratio, gram stain and culture Management was delayed until results were known ‐ "usually 3 to 4 hours" If the L/S ratio was 1.8:1 or greater or if the gram stain demonstrated bacteria the fetus was not included in the study
Interventions	Intervention: 80 women were randomised to corticosteroids and delivery 48 h after treatment with steroids This included betamethasone 12 mg intramuscularly 2 doses 24 h apart Tocolysis used when contractions occurred Delivery was after 48 h by discontinuing the tocolytic and either induction of labour with oxytocin or caesarean section for obstetric indications Control: 80 women were randomised to expectant management Delivered when labour, chorioamnionitis or fetal distress evident Criteria for delivery for women in the expectant management group included: labour chorioamnionitis fetal distress Corticosteroids and tocolysis used in early delivery group. Prophylactic antibiotics not used. Vaginal examinations were not performed in the absence of labour.
Outcomes	Maternal Admission to delivery time Caesarean section Chorioamnionitis: fever ≥ 100.4°F in the absence of other explanations Endometritis Wound infection Urinary tract infection Duration of postpartum hospital stay Fetal Birthweight Gestational age Respiratory distress made when clinical signs and chest X‐ray film were confirmatory infant required > 24 h/oxygen therapy severe RDS: requiring a ventilator Sepsis: not stated as to whether a positive culture required for diagnosis Meningitis Ophthalmitis Pneumonia Necrotising enterocolitis Fetal death Neonatal death
Notes	Gestational age determined by menstrual history and examination, or by a BPD on presentation Rupture of the membranes was documented by sterile speculum examination visualising amniotic fluid pooling in the posterior vaginal vault, alkaline pH by Nitrazine paper and ferning on microscopic examination of fluid from the posterior vaginal fornix.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomisation schema not defined
Allocation concealment (selection bias)	Unclear risk	Not defined
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Blinding not possible due to intervention. However this was likely low risk of bias due to objective and specific assessment criteria for outcomes, where lack of blinding did not affect treatment decisions or other aspects of care.
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Radiologists (for reviewing X‐rays prior to diagnosis of hyaline membrane disease) were blinded as to treatment allocation. However it was not mentioned if all other analysts were blinded to treatment.
Incomplete outcome data (attrition bias) All outcomes	High risk	No losses to follow‐up reported. However, 1 fetal death in expectant management group removed from denominator of neonatal outcomes
Selective reporting (reporting bias)	Unclear risk	Outcomes only reported in results. Not pre‐specified
Other bias	Low risk	None noted